Does your study require ethics review?

  1. Resources for guidelines.
  2. Research requiring ethics review
  3. Research not requiring ethics review
  4. Case studies/reports
  5. Research vs. quality assurance and checklist
  6. Student research

1. Resources

Requirements for ethical review and approval of research involving humans are in compliance with the following guidelines:
  1. Tri- Council Policy Statement on Research involving Human Subjects (TCPS2) Section A. Research Requiring REB Review; Article 2.1
  2. Good Clinical Practice: Consolidated Guideline; ICH Topic E6 Article 4.4 Communication with IRB/IEC/REB (Research Ethics Board, REB)
If, after reading the following information, you have questions regarding the status of your project please contact the HREB office to get direction. Retroactive approval for studies initiated before review and approval is never granted.

The following information is adapted from these guidelines

 2.     Research requiring ethics review and approval before the research begins

From Articles 2.1-2.7
  • Research involving living human participants.
  • Research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. 
  • Research involving observation of people in public places IF there is any kind of intervention by the researcher (interviews, access to private papers), IF the individuals have reasonable expectation of privacy, IF dissemination of results could allow identification of participants.
  • Research involving secondary use of data (use of data collected for purposes other than this research) - health records, computer listings, banked tissue – IF data linkage of recording or dissemination of results could generate identifiable information.

3.  Research not requiring ethics review

The following are examples of activities that do not require review by a research ethics board (REB). These may, nevertheless, raise ethical issues that would benefit from careful consideration outside of the REB.

From Articles 2.5-2.7
  • Research relying exclusively on publicly available information legally accessible to the public and appropriately protected by law through data guardians (e.g. registries of death, court judgements, public archives, data from Statistics Canada) and/or publicly accessible with no reasonable expectation of privacy (e.g. identifiable information in the media, public exhibitions, literary events)
  • Observation of people in public places where there is no intervention by the researcher, no reasonable expectation of privacy, dissemination of research results does not allow identification of participants
  • Research relying exclusively on secondary use of anonymous information or anonymous biological materials so long as data linkage or dissemination of results does not generate identifiable information
  • Quality assurance and quality improvement studies, program evaluation activitie, performance reviews or testing within the educational environment when used exclusively for assessment, management or improvement purposes;  if data are later proposed for research purposes, it would be considered secondary use of information not intended for research purposes and at that time may require REB review, for example:
  • Creative practice activities in and of themselves; research employing creative practices to obtain responses from participants that will be analyze to answer a research question are subject to REB review.
  • Scholarship based on personal reflections and self-study where no one other than the researcher is involved in the research (e.g., autoethnography).
  • Occasions when individuals other than the researcher provide information, but are not themselves the focus of the research such as data collection about organizations, policies, procedures, professional practices or statistical reports;  consultation to frame or develop the research (e.g., a graduate student interviews an agency manager to determine if the data he or she is interested in can be accessed);  website usability testing; discussion with stakeholders and consultants; data collection for internal or external organizational reports.
  • Public health surveillance that is legally mandated
  • Research for a critical biography not involving living participants based exclusively on published or publicly available material.
  • Student assignments that pose minimal risk; teach about the design, conduct and process of research; and might involve “practice” data collection.

4. Case Studies/Reports

Case reports are normally based on the clinical notes of an individual patient/client with the informed consent and do not require research ethics review.

Case studies may be based on documents concerning individuals with or without information collected through personal contact.  Such studies require the individual consent of the subjects of the study and normally require research ethics review. Investigator should contact the HREB if in doubt.

5.  Quality Assurance vs. Research

Q: Is your study program evaluation (which does not require ethics review) or research?

A:   If the intent is internal use for assessment, management or improvement purposes, then it is program evaluation; if the intent is generalizable knowledge (e.g., examining your processes as a case for the purpose of extending knowledge to other similar programs),  then it is research.
 
The following may be present in program evaluation as well as in research and are not useful for determining whether your project requires REB review:
• Intent to publish.   Both research and program evaluation can be published.  Intent to publish does not mean that your project requires REB review. 
• Use of rigorous methods of data collection and data analysis.  Program  evaluation  may share some methods and techniques with those employed in research (such as data collection and data analysis)
 
BE STRATEGIC with the words you use to describe your project as your wording will influence whether an REB or a publisher assumes it is research or program evaluation.  For example, if it is program evaluation, call it that (or refer to it as a “project” or a “program”); do not refer to it as “research”.   Pay attention to how you describe your objectives and rationale or purpose.  Words or phrases that imply that other similar programs will benefit from your study imply that you are doing research, not program evaluation.
 
NO approval ‘after the fact’ can be done.  If a project is done for program evaluation and then it is later decided to use the information for research, then this would be secondary use of data and the REB process for secondary use of data should be followed.
 
Program evaluations involving MUN programs may require a privacy impact assessment through the university’s privacy office.
 
Still need help?
•The HREA website contains a tool created by The Alberta Research Ethics Community Consensus Initiative (ARECCI)   to help determine whether an activity is research or quality assurance  http://www.hrea.ca/Ethics-Review-Required.aspx
 
•TCPS 2 , Article 2.1 (definition of research) and Article  2.5 (exemptions from research) http://www.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter2-chapitre2/
 
•TCPS 2 interpretations posted by the Panel on Research Ethics (items 2 and 7) http://www.ethics.gc.ca/eng/policy-politique/interpretations/scope-portee/
 
•If you are still in doubt about whether your study is program evaluation (which does not require REB review) or research (which does require REB review) please email the Ethics Office (info@hrea.ca) and inquire. Your email should include a summary of the project objectives, method, and purpose.   



Some data collection and analysis in investigations in the health area are not intended to generate scientific knowledge. They are activities used to improve the provision of services or programs to a specific population. The results of the data collection and analysis may be published. These activities are generally referred to as program evaluation or quality assurance/improvement. Investigations of this kind should be approved by the relevant program/institution involved but do not require research ethics review. The following checklist is intended to help the researcher determine whether a study is research or quality assurance/quality improvement/program evaluation.

 
The following is adapted from ALBERTA RESEARCH ETHICS COMMUNITY CONSENSUS INITIATIVE (ARECCI)

Project Primary Purpose: Screening Tool for Determining the Appropriate Route for Ethics Review

This checklist is intended to be used as a pragmatic screening tool to help sort projects by primary purpose to determine the appropriate route for ethics review. That is, is the project research? If so, it should be submitted to an REB. Is the project quality or evaluation? If so, proceed with locally relevant policies for review of quality or evaluation projects. The recommended ethics review process depends on a number of factors (including local policies, level of risk, etc.) and may require further exploration on a project specific basis. This tool has not been validated and is not intended to replace professional judgment and interpretation, but was developed to help increase consistency and transparency of ethics screening processes.

  Question Yes No
1 Is the project funded by, or being submitted to, a research funding agency  for a research grant or award that requires research ethics review  
2 Are there any local policies which require this project to undergo review by a Research Ethics Board?  
  IF YES to either of the above, the project should be submitted to a Research Ethics Board.
IF NO to both questions, continue to complete the checklist.
 
3 Is the primary purpose of the project to contribute to the growing body of knowledge regarding health and/or health systems that are generally accessible through academic literature?  
4 Is the project designed to answer a specific research question or to test an explicit hypothesis?  
5 Does the project involve a comparison of multiple sites, control sites, and/or control groups?  
6 Is the project design and methodology adequate to support generalizations that go beyond the particular population the sample is being drawn from?  
7 Does the project impose any additional burdens on participants beyond what would be expected through a typically expected course of care or role expectations?  
  LINE A: SUBTOTAL Questions 3 through 7 = (Count the # of Yes responses)    
8 Are many of the participants in the project also likely to be among those who might potentially benefit from the result of the project as it proceeds?  
9 Is the project intended to define a best practice within your organization or practice?  
10 Would the project still be done at your site, even if there were no opportunity to publish the results or if the results might not be applicable anywhere else?  
11 Does the statement of purpose of the project refer explicitly to the features of a particular program,
Organization, or region, rather than using more general terminology such as rural vs. urban populations?
 
12 Is the current project part of a continuous process of gathering or monitoring data within an organization?    
  LINE B: SUBTOTAL Questions 8 through 12 = (Count the # of Yes responses)    

Interpretation:
  • If the sum of Line A is greater than Line B, the most probable purpose is research. The project should be submitted to an REB.
  • If the sum of Line B is greater than Line A, the most probable purpose is quality/evaluation. Proceed with locally relevant process for ethics review (may not necessarily involve an REB).
  • If the sums are equal, seek a second opinion to further explore whether the project should be classified as Research or as Quality and Evaluation.
*Source of ARECCI Recommendations: Protecting People While Increasing Knowledge: Recommendations for a Province wide Approach to Ethics Review of Knowledge Generating Projects (Research, Program Evaluation, and Quality Improvement) in Health Care [December 2005), Alberta Research Ethics Community Consensus Initiative (ARECCI). For more information visit the ARECCI website at www.ahfmr.ab.ca/arecci

6.     Student Research

The requirements for ethics review of the research studies of undergraduate, graduate and postgraduate students and the level of scrutiny are the same as those applying to non-student researchers. 

A.     Student applications:
  • All students are expected to complete all documentation required for review and discuss with their instructor or supervisor the completed application which must be signed by both the student and faculty member.  In cases where a graduate student is working on a component of a much larger piece of research, it is expected that the student will clearly delineate the boundaries of his/her project and state the objectives specific to their thesis project.   
  • Graduate students are expected to submit their applications as the principal investigator for their thesis research.  As the primary investigator they and their supervisor would be held accountable for any breach of research ethics.
B.    Studies that are part of undergraduate course requirements:

 In some cases the HREB may approve simple research exercises included as a requirement in an undergraduate course (e.g., short doorstep interviews with persons from four randomly selected households) along with accompanying course material instructing the students in the relevant ethical issues.  This approval is renewed year to year and eliminates the necessity for each student group to submit individual applications. The course professor submits a letter of request, describing the course and providing course materials, and acts as the contact person for all interactions with the REB.

Type of review: Student research is regarded as a means of acquiring research skills.  It is assumed that most undergraduate studies will be of minimal risk (see Chapter 2 B in TCPS2)  and applications will receive expedited review.  However, any student project deemed by the HREB to be of greater than minimal risk will be sent for review by the full committee.  
 

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